scholarly journals Validation of diffusion MRI as a biomarker for efficacy using randomized phase III trial of bevacizumab with or without VB-111 in recurrent glioblastoma

2021 ◽  
Author(s):  
Benjamin M Ellingson ◽  
Kunal Patel ◽  
Chencai Wang ◽  
Catalina Raymond ◽  
Andrew Brenner ◽  
...  
Keyword(s):  
Diffusion Mri ◽  
Tumor Volume ◽  
Cox Regression ◽  
Controlled Trial ◽  
Univariate Analysis ◽  
Recurrent Glioblastoma ◽  
Phase Iii ◽  
Imaging Biomarker ◽  
Imaging Biomarkers ◽  
Phase Ii Trials

Abstract Background Evidence from single and multicenter phase II trials have suggested diffusion MRI is a predictive imaging biomarker for survival benefit in recurrent glioblastoma (rGBM) treated with anti-VEGF therapy. The current study confirms these findings in a large, randomized phase III clinical trial. Methods Patients with rGBM were enrolled in a phase III randomized (1:1), controlled trial (NCT02511405) to compare the efficacy and safety of bevacizumab (BV) versus BV in combination with ofranergene obadenovec (BV+VB-111), an anti-cancer viral therapy. In 170 patients with diffusion MRI available, pre-treatment enhancing tumor volume and ADC histogram analysis were used to phenotype patients as having high (>1.24 um 2/ms) or low (< 1.24 um 2/ms) ADCL, the mean value of the lower peak of the ADC histogram, within the contrast enhancing tumor. Results Baseline tumor volume (P=0.3460) and ADCL (P=0.2143) did not differ between treatment arms. Univariate analysis showed patients with high ADCL had a significant survival advantage in all patients (P=0.0006), as well as BV (P=0.0159) and BV+VB-111 individually (P=0.0262). Multivariable Cox regression accounting for treatment arm, age, baseline tumor volume and ADCL identified continuous measures of tumor volume (P<0.0001; HR=1.0212) and ADCL phenotypes (P=0.0012; HR=0.5574) as independent predictors of OS. Conclusion Baseline diffusion MRI and tumor volume are independent imaging biomarkers of OS in rGBM treated with BV or BV+VB-111.

scholarly journals NIMG-17. VALIDATION OF DIFFUSION MRI AS AN IMAGING BIOMARKER FOR BEVACIZUMAB THERAPY IN RECURRENT GLIOBLASTOMA IN A RANDOMIZED PHASE III TRIAL OF BEVACIZUMAB WITH OR WITHOUT VB-111 (GLOBE)

2020 ◽  
Vol 22 (Supplement_2) ◽  
pp. ii150-ii150
Author(s):  
Benjamin Ellingson ◽  
Timothy Cloughesy ◽  
Chencai Wang ◽  
Kunal Patel ◽  
Catalina Raymond ◽  
...  
Keyword(s):  
Diffusion Mri ◽  
Tumor Volume ◽  
Univariate Analysis ◽  
Gaussian Model ◽  
Recurrent Glioblastoma ◽  
Phase Iii ◽  
Imaging Biomarker ◽  
Imaging Biomarkers ◽  
Phase Ii Trials ◽  
Anti Vegf

Abstract BACKGROUND Evidence from independent single center as well as multicenter phase II trials have suggested diffusion MRI is a strong predictive imaging biomarker for survival benefit in recurrent glioblastoma (rGBM) treated with anti-VEGF monotherapy, but not systemic chemotherapies or combination therapies with anti-VEGF agents. The current study builds on this body of evidence by evaluating these diffusion MR phenotypes in a large randomized phase III clinical trial. METHODS Patients with rGBM were enrolled in a phase III randomized (1:1), controlled trial (NCT02511405) to compare the efficacy and safety of bevacizumab (BV) versus bevacizumab in combination with ofranergene obadenovec (BV+VB-111), an anti-cancer viral therapy. In 170 patients with diffusion MRI available, pre-treatment enhancing tumor volume and ADC histogram analysis were used to phenotype patients as having high (>1.24 um2/ms) or low (< 1.24 um2/ms) ADCL, the mean value of the lower peak in a double Gaussian model of the ADC histogram within the contrast enhancing tumor. RESULTS Baseline tumor volume (P=0.3460) and ADCL (P=0.2143) did not differ between treatment arms. Univariate analysis showed that patients with high ADCL had a significant survival advantage when pooling all patients (P=0.0006), as well as when examining the BV (P=0.0159) and BV+VB-111 individually (P=0.0262). Multivariable Cox regression accounting for treatment arm, age, baseline tumor volume and ADCL identified continuous measures of tumor volume (P< 0.0001; HR=1.0212) and ADCL phenotypes (P=0.0012; HR=0.5574) as independent predictors of OS. CONCLUSION Baseline diffusion MRI and tumor volume are independent imaging biomarkers of OS in rGBM treated with BV or BV+VB-111. Since ADCL was predictive of OS in combination BV+VB-111, results support the working hypothesis that co-administration of VB-111 with BV may block any VB-111 anti-tumor effect, whereas VB-111 monotherapy or priming may result in higher efficacy of VB-111.

scholarly journals Validation of diffusion MRI phenotypes for predicting response to bevacizumab in recurrent glioblastoma: post-hoc analysis of the EORTC-26101 trial

2020 ◽  
Vol 22 (11) ◽  
pp. 1667-1676
Author(s):  
Marianne Schell ◽  
Irada Pflüger ◽  
Gianluca Brugnara ◽  
Fabian Isensee ◽  
Ulf Neuberger ◽  
...  
Keyword(s):  
Phase Ii ◽  
Diffusion Mri ◽  
Cox Regression ◽  
Threshold Model ◽  
Prognostic Significance ◽  
Predictive Ability ◽  
Progression Free Survival ◽  
Recurrent Glioblastoma ◽  
Imaging Biomarker ◽  
Molecular Characteristics

Abstract Background This study validated a previously described diffusion MRI phenotype as a potential predictive imaging biomarker in patients with recurrent glioblastoma receiving bevacizumab (BEV). Methods A total of 396/596 patients (66%) from the prospective randomized phase II/III EORTC-26101 trial (with n = 242 in the BEV and n = 154 in the non-BEV arm) met the inclusion criteria with availability of anatomical and diffusion MRI sequences at baseline prior treatment. Apparent diffusion coefficient (ADC) histograms from the contrast-enhancing tumor volume were fitted to a double Gaussian distribution and the mean of the lower curve (ADClow) was used for further analysis. The predictive ability of ADClow was assessed with biomarker threshold models and multivariable Cox regression for overall survival (OS) and progression-free survival (PFS). Results ADClow was associated with PFS (hazard ratio [HR] = 0.625, P = 0.007) and OS (HR = 0.656, P = 0.031). However, no (predictive) interaction between ADClow and the treatment arm was present (P = 0.865 for PFS, P = 0.722 for OS). Independent (prognostic) significance of ADClow was retained after adjusting for epidemiological, clinical, and molecular characteristics (P ≤ 0.02 for OS, P ≤ 0.01 PFS). The biomarker threshold model revealed an optimal ADClow cutoff of 1241*10–6 mm2/s for OS. Thereby, median OS for BEV-patients with ADClow ≥ 1241 was 10.39 months versus 8.09 months for those with ADClow < 1241 (P = 0.004). Similarly, median OS for non-BEV patients with ADClow ≥ 1241 was 9.80 months versus 7.79 months for those with ADClow < 1241 (P = 0.054). Conclusions ADClow is an independent prognostic parameter for stratifying OS and PFS in patients with recurrent glioblastoma. Consequently, the previously suggested role of ADClow as predictive imaging biomarker could not be confirmed within this phase II/III trial.

scholarly journals Quantification of contrast-uptake as imaging biomarker for disease progression of renal cell carcinoma after tumor ablation

2020 ◽  
Vol 61 (12) ◽  
pp. 1708-1716
Author(s):  
Bruno R Tegel ◽  
Steffen Huber ◽  
Lynn J Savic ◽  
MingDe Lin ◽  
Bernhard Gebauer ◽  
...  
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Tumor Volume ◽  
Cox Regression ◽  
Imaging Biomarker ◽  
Imaging Biomarkers ◽  
Secondary Outcome ◽  
Tumor Diameter ◽  
Renal Metastases

Background The prognosis of patients with renal cell carcinoma (RCC) depends greatly on the presence of extra-renal metastases. Purpose To investigate the value of total tumor volume (TTV) and enhancing tumor volume (ETV) as three-dimensional (3D) quantitative imaging biomarkers for disease aggressiveness in patients with RCC. Material and Methods Retrospective, HIPAA-compliant, IRB-approved study including 37 patients with RCC treated with image-guided thermal ablation during 2007–2015. TNM stage, RENAL Nephrometry Score, largest tumor diameter, TTV, and ETV were assessed on cross-sectional imaging at baseline and correlated with outcome measurements. The primary outcome was time-to-occurrence of extra-renal metastases and the secondary outcome was progression-free survival (PFS). Correlation was assessed using a Cox regression model and differences in outcomes were shown by Kaplan–Meier plots with significance and odds ratios (OR) calculated by Log-rank test/generalized Wilcoxon and continuity-corrected Woolf logit method. Results Patients with a TTV or ETV > 5 cm3 were more likely to develop distant metastases compared to patients with TTV (OR 6.69, 95% confidence interval [CI] 0.33–134.4, P=0.022) or ETV (OR 8.48, 95% CI 0.42–170.1, P=0.016) < 5 cm3. Additionally, PFS was significantly worse in patients with larger ETV ( P = 0.039; median PFS 51.87 months vs. 69.97 months). In contrast, stratification by median value of the established, caliper-based measurements showed no significant correlation with outcome parameters. Conclusion ETV, as surrogate of lesion vascularity, is a sensitive imaging biomarker for occurrence of extra-renal metastatic disease and PFS in patients with RCC.

Phase II trial of Gliadel plus O6-benzylguanine (O6-BG) for patients with recurrent glioblastoma multiforme

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 1568-1568 ◽  
Author(s):  
J. A. Quinn ◽  
J. J. Vredenburgh ◽  
J. N. Rich ◽  
D. A. Reardon ◽  
A. Desjardins ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Adverse Events ◽  
Median Survival ◽  
Controlled Trial ◽  
Recurrent Glioblastoma ◽  
Phase Iii ◽  
Csf Leak ◽  
Recurrent Glioblastoma Multiforme ◽  
Major Mechanism ◽  
Phase 2 Trial

1568 Background. The major mechanism of resistance to alkylnitrosourea therapy involves the DNA repair protein O6-alkylguanine-DNA alkyltransferase (AGT) which removes chloroethylation or methylation damage from the O6-position of guanine. O6-BG is an AGT substrate that inhibits AGT by suicide inactivation. A previous phase III randomized, placebo-controlled trial has shown that Gliadel wafer significantly prolongs 6-month survival (55.5% for Gliadel vs. 35.6% for placebo) and median survival (28 weeks for Gliadel vs. 20 weeks for placebo) in patients with recurrent glioblastoma multiforme (GBM) (Brem et al 1995). Despite the success of Gliadel in prolonging survival we may be able to improve on this success by depleting AGT. Methods. Thus, we have designed a phase 2 trial where we define the activity and the toxicity of Gliadel in combination with a 5-day infusion of O6-BG in patients with recurrent GBM. In a prior study the O6-BG dose found to be effective in depleting tumor AGT activity at 48 hours was an IV bolus of 120 mg/m2 over 1 hour followed by a continuous infusion of 30 mg/m2/d for 48 hours. In order to guarantee depletion of tumor AGT activity for at least 5 days after Gliadel placement, this O6-BG bolus was repeated on days 3 and 5 while continuing the infusion. Results. To date, 24 patients have been enrolled out of a planned accrual of 50 patients. Seventeen of these patients received prior nitrosourea therapy. The 6-month survival is 68% and the median survival is 36 weeks. The adverse events include the following: 2 episodes of CSF leak (8%), 4 episodes of wound infection at craniotomy site (16%), 5 episodes of grade ≥ 3 seizures (21%) and 3 episodes of hyponatremia (12%). These adverse events were similar in frequency to those seen in patients receiving Gliadel in prior placebo-controlled Gliadel trials. Conclusions. Thus far, this data demonstrates an increase in the efficacy of Gliadel when combined with O6-BG. Twenty-six additional patients will be enrolled for a total accrual of 50 patients. [Table: see text]

Phase II trial of Gliadel plus O6-benzylguanic (O6-BG) for patients with recurrent glioblastoma multiforme

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 2036-2036 ◽  
Author(s):  
J. A. Quinn ◽  
J. J. Vredenburgh ◽  
J. N. Rich ◽  
D. A. Reardon ◽  
A. Desjardins ◽  
...  
Keyword(s):  
Glioblastoma Multiforme ◽  
Median Survival ◽  
Controlled Trial ◽  
Recurrent Glioblastoma ◽  
Phase Iii ◽  
Csf Leak ◽  
Recurrent Glioblastoma Multiforme ◽  
Major Mechanism ◽  
Phase 2 Trial ◽  
Grade 3

2036 Background: The major mechanism of resistance to alkylnitrosourea therapy involves the DNA repair protein O6-alkylguanine-DNA alkyltransferase (AGT) which removes chloroethylation or methylation damage from the O6- position of guanine. O6-BG is an AGT substrate that inhibits AGT by suicide inactivation. A previous phase III randomized, placebo- controlled trial has shown that Gliadel wafer (G) significantly prolongs 6-month survival (55.5% for G vs. 35.6% for placebo) and median survival (28 weeks for G vs. 20 weeks for placebo) in patients with recurrent glioblastoma multiforme (GBM) (Brem et al 1995). Despite the success of G in prolonging survival we may be able to improve on this success by depleting AGT. Methods: Thus, we have designed a phase 2 trial where we define the activity and the toxicity of G in combination with a 5-day infusion of O6-BG in patients with recurrent GBM. In a prior study the O6-BG dose found to be effective in depleting tumor AGT activity at 48 hours was an IV bolus of 120 mg/m2 over 1 hour followed by a continuous infusion of 30 mg/m2/d for 48 hours. In order to guarantee depletion of tumor AGT activity for at least 5 days after G placement, this O6-BG bolus was repeated on days 3 and 5 while continuing the infusion. Results: To date, 47 patients have been enrolled out of a planned accrual of 50 patients. The 6-month survival is 80% and the median survival is 47 weeks. The adverse events include the following: 3 episodes of grade 3 CSF leak (6%), 7 episodes of grade 3 wound infection at craniotomy site (15%), 6 episodes of hyponatremia (13%), 3 episodes of hydrocephalus (6%), 1 episode of hygroma (2%), 1 episode of infectious meningitis (2%), 1 episode of arachnoiditis (2%), 1 episode of grade 3 fever (2%). Conclusions: Thus far, this data demonstrates an increase in the efficacy of G when combined with O6-BG. Three additional patients will be enrolled for a total accrual of 50 patients. [Table: see text]

Single nucleotide polymorphisms (SNPs) in COL4A2, PPP1R17, and ARHGAPP44 and prognostic value in metastatic colorectal cancer (mCRC).

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 720-720
Author(s):  
Amanda Rose Townsend ◽  
Rebecca Asher ◽  
Timothy Jay Price ◽  
Chee Khoon Lee ◽  
Hilary Dorward ◽  
...  
Keyword(s):  
Treatment Response ◽  
Regression Models ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Prognostic Significance ◽  
Progression Free Survival ◽  
Phase Iii ◽  
Prognostic Impact ◽  
Nucleotide Polymorphisms ◽  
Significant Difference

720 Background: Our previous study has identified COL4A2, PPP1R17 and ARHGAP44 SNPs using whole exome sequencing with potential prognostic significance (Townsend et al. ASCO GI 2017). COL4A2 encodes a subunit of type IV collagen, the C-terminal of which is an inhibitor of angiogenesis. We assessed prognostic impact of these variants in patients from the phase III MAX study (capecitabine +/- bevacizumab (+/- mitomycin C)). An analysis of predictive effect on bevacizumab was also undertaken. Methods: DNA was extracted from archival macrodissected formalin fixed paraffin embedded tumor tissue and genotyped using Agena Bioscience MassARRAY system (AGRF). Univariate association of variant group (WT versus mutation (MT)) with progression free survival (PFS) and overall survival (OS) was assessed using Kaplan-Meier curves and Cox regression models. Logistic regression models were used to assess association with response rate (RR). A cox regression model with treatment, variant status and their interaction investigated if variants were predictive of bevacizumab effect. Results: Of the available 145 of 471 (31%) patients in the MAX study, 25 (17%) had COL4A2 MT, 29 (20%) PPP1R17 MT, 14 (10%) ARHGAP44 MT. Patient demographics were comparable across treatment groups and outcomes similar to whole study population. On univariate analysis median PFS was numerically longer for WT vs MT in all 3 variants, but these differences were not significant (COL4A2 WT 8.4m v MT 6.0m, p=0.09; PPP1R17 WT 7.8m v MT 7.5m, p=0.76; ARHGAP44 WT 8.2m v MT 6.5m, p=0.86). There was also no significant association between variant type and OS. Multivariate analysis for COL4A2 MT v WT showed no significant difference in PFS or OS (HR 1.42; 95% CI 0.91-2.22, p=0.13 and HR 1.33; 95% CI 0.85-2.1, p=0.21). There was no association between treatment response and variant status. Variant status was not predictive of bevazicumab efficacy for treatment response, PFS or OS. Conclusions: There was no significant prognostic or predictive impact of novel gene variants in patients treated with bevacizumab. This may be due to small numbers of MT variants in this study and further studies in larger populations may be useful.

Sequencing chemotherapy and surgery in upper tract urothelial cancers.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 521-521
Author(s):  
Saurabh Parasramka ◽  
Alex Cook ◽  
Zin Myint ◽  
Ding Xue ◽  
Jianrong Wu ◽  
...  
Keyword(s):  
Renal Pelvis ◽  
Cox Regression ◽  
Early Stage ◽  
Univariate Analysis ◽  
Disease Free Survival ◽  
Phase Iii ◽  
High Grade ◽  
Upper Tract ◽  
Significant Survival ◽  
Urothelial Bladder

521 Background: Prognosis for high grade, non-metastatic upper tract urothelial carcinoma (UTUC) (renal pelvis or ureter) has not improved in past two decades. Given improvements in disease-free survival in phase III POUT study, adjuvant chemotherapy (AC) has been the preferred approach. Neoadjuvant chemotherapy (NAC) is favored based on median survival (OS) benefit seen in urothelial bladder cancer. We studied National Cancer Database (NCDB) to answer this question. Methods: We identified adults > 18 years with non-metastatic, high grade, UTUC. All patients received surgery of the primary site and chemotherapy in the neoadjuvant or adjuvant setting. Patient’s receiving radiation therapy or who died within 90 days of surgery were not included. Descriptive statistics, log-rank tests and cox-regression tests were performed. Patients achieving complete pathological response (pCR) defined as (pTis, pT0, pTa and N0) were assessed for OS. Results: 1191 patients with complete data were identified; 225 (19%) received NAC and 966 (81%) received AC. 60% were males, median age was 68 and 73% had Charlson score (CS) of ‘0’. Median follow-up time for alive patients was 30.4 and 36.7 months in the NAC and AC groups respectively. Renal pelvis was the primary in 760 cases (63%) and ureter in 441 (37%). On univariate analysis receiving NAC, age < 75 years and CS score ‘0’ was associated with significant survival benefit (p < 0.05). Similarly on multivariate analysis receiving NAC and having CS of ‘0’ had significantly better survival with HR 0.75 (CI 0.58-0.96) and 0.8 (CI 0.65-0.96) respectively. Age > 75 years had worse survival HR 1.34 (CI 1.08-1.66). Thirty-seven patients (17%) in the NAC group achieved pCR with OS > 71.6 months which was significantly better than AC group and non-responders in the NAC group (p < 0.05). There was a trend towards more benefit with NAC compared to AC in Stage 1 and 2 UTUC than in Stage 3 and 4. Conclusions: Our study indicates that subset of early stage UTUC benefit more from NAC comparing to AC. However, randomized prospective study is warranted to further explore the role of NAC in UTUC.

The Role of Delayed Radiotherapy Initiation in Patients with Newly Diagnosed Glioblastoma with Residual Tumor Mass

2021 ◽  
Author(s):  
Johannes Kasper ◽  
Clara Frydrychowicz ◽  
Katja Jähne ◽  
Tim Wende ◽  
Florian Wilhelmy ◽  
...  
Keyword(s):  
Dna Methyltransferase ◽  
Tumor Volume ◽  
Cox Regression ◽  
Statistical Significance ◽  
Univariate Analysis ◽  
Residual Tumor ◽  
Rank Test ◽  
Survival Prediction ◽  
Newly Diagnosed ◽  
Entire Cohort

Abstract Objective Treatment for newly diagnosed isocitrate dehydrogenase (IDH) wild-type glioblastoma (GBM) includes maximum safe resection, followed by adjuvant radio(chemo)therapy (RCx) with temozolomide. There is evidence that it is safe for GBM patients to prolong time to irradiation over 4 weeks after surgery. This study aimed at evaluating whether this applies to GBM patients with different levels of residual tumor volume (RV). Methods Medical records of all patients with newly diagnosed GBM at our department between 2014 and 2018 were reviewed. Patients who received adjuvant radio (chemo) therapy, aged older than 18 years, and with adequate perioperative imaging were included. Initial and residual tumor volumes were determined. Time to irradiation was dichotomized into two groups (≤28 and >28 days). Univariate analysis with Kaplan–Meier estimate and log-rank test was performed. Survival prediction and multivariate analysis were performed employing Cox proportional hazard regression. Results One hundred and twelve patients were included. Adjuvant treatment regimen, extent of resection, residual tumor volume, and O6-methylguanine DNA methyltransferase (MGMT) promoter methylation were statistically significant factors for overall survival (OS). Time to irradiation had no impact on progression-free survival (p = 0.946) or OS (p = 0.757). When stratified for different thresholds of residual tumor volume, survival predication via Cox regression favored time to irradiation below 28 days for patients with residual tumor volume above 2 mL, but statistical significance was not reached. Conclusion Time to irradiation had no significant influence on OS of the entire cohort. Nevertheless, a statistically nonsignificant survival prolongation could be observed in patients with residual tumor volume > 2 mL when admitted to radiotherapy within 28 days after surgery.

scholarly journals The efficacy and safety of Anyu Peibo Capsule in the treatment of patients with major depressive disorder in China: study protocol for a randomized placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jingjing Huang ◽  
Yimin Yu ◽  
Yi Jiang ◽  
Wu Chen ◽  
Yan Li ◽  
...  
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Rating Scale ◽  
Controlled Trial ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Phase Ii Trials ◽  
Major Depressive ◽  
Link Type ◽  
Double Blinded

Abstract Background Major depressive disorder is the second leading cause of years lost to disability worldwide. Anyu Peibo Capsule has been shown to be effective and safe in phase II trials. Methods This clinical study is a multi-center, randomized, double-blinded, placebo-controlled, parallel-group, phase III trial of Anyu Peibo Capsule in China. The aim is to test whether the administration of Anyu Peibo Capsule compared to placebo improves clinical outcomes in adults (aged 18 to 65 years) with MDD. Patients will receive an 8-week treatment of Anyu Peibo Capsule 1.6 g per day or placebo. The primary outcome will be the change from baseline in the total score for the Montgomery-Asberg Depression Rating Scale at the end of the 8-week treatment. Discussion The trial aims to provide pivotal evidence for the efficacy and safety of Anyu Peibo Capsule in patients with major depressive disorder. Trial registration ClinicalTrials.govNCT04210973. Registered on December 26, 2019

scholarly journals Hemoglobin, albumin, lymphocytes and platelets (HALP) score is a useful predictor of survival in patients with recurrent glioblastoma multiforme treated with bevacizumab plus irinotecan

2021 ◽  
Author(s):  
Mustafa Korkmaz ◽  
Melek Karakurt Eryılmaz ◽  
Mehmet zahid koçak ◽  
Aykut Demirkıran ◽  
mustafa Karaağaç ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Cox Regression ◽  
Univariate Analysis ◽  
Predictive Marker ◽  
Recurrent Glioblastoma ◽  
Significant Prognostic Factor ◽  
Recurrent Glioblastoma Multiforme ◽  
Poor Prognostic Factor ◽  
Cox Regression Analysis ◽  
Recurrent Gbm

Abstract Backgrounds: We aimed to investigate whether the HALP score is a predictive marker in patients with recurrent GBM who were given bevacizumab plus irinotecan.Methods: We compared the survival of patients followed up in our clinic with the diagnosis of recurrent GBM and treated with bevacizumab plus irinotecan, according to HALP score.Results: Median PFS and OS were 4.5 (0.9-14.9) and 8 (0.9-21.3) months, respectively. The median PFS of the low HALP score group was 1.85 (1.3-3.37) months, and of the high HALP score group was 4.96 (0.9-14.9) months (p=0.03). The OS of the high HALP score group (9.63 [7.28-11.9]) was statistically higher compared with low HALP score group (2.26 [0.88-3.65]) (p<0.001). In univariate analysis HALP score was a significant prognostic factor; patients with low HALP score had a poorer prognosis than high HALP score (HR: 0.063, p<0.001). The multivariate analysis showed that HALP score (p=0.003), and residual tumor (p=0.029) were significant prognostic factors. In multivariate Cox regression analysis, low HALP score was a significant poor prognostic factor for OS compared with high HALP score (HR: 0.063, p<0.001). Conclusion: We showed that the HALP score at the start of treatment is an independent prognostic factor for PFS and OS in patients with recurrent GBM treated with bevacizumab plus irinotecan. The HALP score, which can be easily calculated by routine tests before chemotherapy, can be used as a predictive marker for bevacizumab treatment decision.

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